Sara Gerke

Assistant Professor of Law

Sara Gerke joined Penn State Dickinson Law as assistant professor of law in July 2021. Her current research focuses on the ethical and legal challenges of artificial intelligence and big data for health care and health law in the United States and Europe. She also researches comparative law and ethics of other issues at the cutting edge of medical developments, such as the clinical translation of stem cell research, biological products, such as somatic cells, tissues, and gene therapy, reproductive medicine, such as mitochondrial replacement techniques, and digital health more generally.

Professor Gerke is leading several research projects. She is the co-principal investigator of the study of the legal and ethical implications raised by AI-assisted surgery in the interdisciplinary project CLASSICA (Validating AI in Classifying Cancer in Real-Time Surgery). This project is funded by the European Union through the Horizon Europe funding program with a total of €6 million for four years with 11 partners from nine countries. She also spearheads, as co-principal investigator, the study on addressing ethical and legal concerns raised by AI in colonoscopy in the interdisciplinary project OperA (Optimizing Colorectal Cancer Prevention Through Personalized Treatment With Artificial Intelligence). This five-year project consists of 18 partners from 13 countries and received a total of €6 million in funding (i.e., €4.7 million from Horizon Europe and the remainder from a U.K. funding body).

Professor Gerke is also co-leading the project BLAST (Bioethical, Legal, and Anthropological Study of Technologies), supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institutes of Health Office of the Director (NIH OD). This project focuses on robotics, bionics, and bioprinting. Moreover, Professor Gerke is the co-investigator of the supplemental project “PREMIERE: A PREdictive Model Index and Exchange Repository,” supported by the NIBIB and NIH OD. This project was also supported in part by the Rock Ethics Institute at Penn State University and explores the ethics of synthetic data and the utility of ELSI-focused computational checklists for biomedical AI/ML. Professor Gerke is also a co-investigator of the project TCORS: Tobacco Product Composition Effects on Toxicity, supported by the National Institute on Drug Abuse (NIDA)/NIH. 

Professor Gerke has over 60 publications in health law and bioethics, especially AI and digital health. Her work has appeared in leading law, medical, scientific, and bioethics journals, such as The George Washington Law Review, Yale Journal of Health Policy, Law, and Ethics, JAMA, Science, Nature Medicine, npj Digital Medicine, Nature Machine Intelligence, Nature Biotechnology, The Lancet Digital Health, Journal of Law and the Biosciences, Journal of Law, Medicine & Ethics, Hastings Center Report, and The American Journal of Bioethics, as well as books published by Cambridge University Press, Elsevier, and Springer. She is also the first editor of a stakeholder book on the clinical application of human induced pluripotent stem cells published with Springer in 2020.

Professor Gerke was also named a 2021 Health Law Scholar by the American Society for Law, Medicine & Ethics and the Saint Louis University School of Law Center for Health Law Studies.

At Penn State Dickinson Law, Professor Gerke teaches Torts, Health Care Law & Policy, and Food and Drug Law. With her expertise in the ethics and law of AI, big data, and digital health, she has also been frequently invited as a guest lecturer at other schools, such as Harvard Medical School, Harvard T.H. Chan School of Public Health, Massachusetts Institute of Technology, and McGill University, Faculty of Medicine and Health Sciences.

Professor Gerke previously served as a Research Fellow in Medicine, Artificial Intelligence, and Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, where she oversaw the day-to-day work of the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), including conducting law, policy, and ethics research; drafting reports and recommendations; and coordinating the Center’s efforts with collaborators at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen as well as other partners. Before joining the Petrie-Flom Center at Harvard Law School, Professor Gerke was the General Manager of the Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim (IMGB).

Professor Gerke has presented her work at national and international legal, medical, bioethics, industry, and stakeholder conferences and meetings organized, for example, by the U.S. Department of Health and Human Services, National Academy of Medicine Leadership Consortium, The President’s Cancer Panel, Harvard Law School, Harvard Business School, Stanford Law School, Boston Bar Association, University of Copenhagen, University of Cambridge, University College London, and the University of Oxford. She has also co-organized a variety of conferences and events, such as Black-Box Medicine: Legal and Ethical Issues and AI and Disability/Dependency: Equity, Access, and Interdependence.

Professor Gerke is a member of several working groups and committees. For example, she is an editorial board member of npj Digital Medicine, a member of the the Federation of State Medical Boards of the United States (FSMB) Ethics and Professionalism Committee, a member of the American Telemedicine Association (ATA) Data Privacy Workgroup, a member of the  Penn State Cancer Institute, a member of the Advisory Group — Academic — of the American Board of AI in Medicine (ABAIM), and a member of the Ethical, Legal, and Social Issues (ELSI) Group of DARPA’s ADvanced Acclimation and Protection Tool for Environmental Readiness (ADAPTER) program. She is also the co-initiator of the ELSI Strategic Working Group at the German Stem Cell Network (GSCN).

From April 2016 to March 2018, Professor Gerke was also the co-investigator of an interdisciplinary project, known as “ClinhiPS,” sponsored by the German Federal Ministry of Education and Research (funds: €657,678.00). This project analyzed the clinical application of human induced pluripotent stem cells in Germany and Austria from scientific, ethical, and comparative legal perspectives.

Professor Gerke earned a degree in law (Dipl.-Jur. Univ.; J.D. equivalent) in July 2012 from the University of Augsburg with distinction-level results. She also holds a Master’s degree in Medical Ethics and Law from King’s College London (December 2013), and achieved a distinction in her Master’s dissertation entitled “A Market in Human Organs from the Living or an Opt-Out System? A Legal and Ethical Analysis to Identify a Way to Address the Organ Shortage in the United Kingdom”. In addition, she expects her Dr. iur. (Ph.D. in Law equivalent) on the regulation of stem cell research in Europe to be officially awarded from the University of Mannheim this year.

Select Publications by Professor Gerke

Sara Gerke, “Nutrition Facts Labels” for Artificial Intelligence/Machine Learning-Based Medical Devices—The Urgent Need for Labeling Standards, 91 The George Washington Law Review 79 (2023).

Sara Gerke, Health AI for Good Rather than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices, 20 Yale Journal of Health Policy, Law, and Ethics 433 (2021, published April 2022). 

Sara Gerke, Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward, in The Future of Medical Device Regulation: Innovation and Protection (I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson & Carmel Shachar eds., Cambridge University Press, 2022).

Sara Gerke, Timo Minssen & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare, in Artificial Intelligence in Healthcare 295 (Adam Bohr & Kaveh Memarzadeh eds., Elsevier 2020).  

Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19, 26 NATURE MED. 1176 (2020). 

Sara Gerke, Ariel D. Stern & Timo Minssen, Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries, 3 NPJ DIGIT. MED. Article number: 94 (2020).

Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device, 3 NPJ DIGIT. MED. Article number: 53 (2020).  

Sara Gerke, Serena Yeung & I. Glenn Cohen, Ethical and Legal Aspects of Ambient Intelligence in Hospitals, 323 JAMA 601 (2020).

 Sara Gerke

Email  sgerke@psu.edu

Phone 717-240-5138

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Prof. Gerke in the Media

Prof. Gerke’s Selected Works

Faculty Impact

Education
Dipl.-Jur. Univ., University of Augsburg

M.A. in Medical Ethics and Law, King’s College London

Research Interests
Health Law (including bioethics, artificial intelligence, digital health, stem cell research, genetics, reproductive technology, and other health law topics), Food and Drug Law, Privacy Law, Law and Medicine, Law and Technology, Torts, and Comparative Law (the U.S. and Europe)

Current Courses
Torts

Health Law

Food and Drug Law
Gerke’s Publications

Edited Book

Sara Gerke, Jochen Taupitz, Claudia Wiesemann, Christian Kopetzki & Heiko Zimmermann (eds.), Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen — Ein Stakeholder-Sammelband [The Clinical Application of Human Induced Pluripotent Stem Cells — A Stakeholder Anthology] (Springer 2020).

Journal Articles

Sara Gerke & Delaram Rezaeikhonakdar, “Privacy Shield 2.0 – A New Trans-Atlantic Data Privacy Framework Between the European Union and the United States,” 45 CARDOZO LAW REVIEW 2 (2023, published February 2024).

Mindy Duffourc & Sara Gerke, “Health Care AI and Patient Privacy — Dinerstein v Google,” JAMA (2024).

Mindy Duffourc & Sara Gerke, “Decoding US Tort Liability in Healthcare’s Black-Box Era: Lessons from the EU,” 27 STANFORD TECHNOLOGY LAW REVIEW 1 (2024).

Eugenia N. Uche-Anya, Sara Gerke & Tyler M. Berzin, “Video Endoscopy as Big Data: Balancing Privacy and Progress in Gastroenterology,” THE AMERICAN JOURNAL OF GASTROENTEROLOGY (2024).

I. Glenn Cohen, Boris Babic, Sara Gerke, Qiong Xia, Theodoros Evgeniou & Klaus Wertenbroch, “How AI Can Learn from the Law: Putting Humans in the Loop Only on Appeal,” 6 NPJ DIGITAL MEDICINE Article number: 160 (2023).

Mindy N. Duffourc & Sara Gerke, “Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients,” JAMA (2023).

Rosh Walsh, Emma C. Kearns, Alice Moynihan, Sara Gerke, Mindy Duffourc, Marcelo Corrales Compagnucci, Timo Minssen & Ronan A Cahill, “Ethical Perspectives on Surgical Video Recording for Patients, Surgeons and Society: Systematic Review,” 7 BJS OPEN zrad063 (2023).

Dennis M. Hedderich, Christian Weisstanner, Sofe Van Cauter, Christian Federau, Myriam Edjlali, Alexander Radbruch, Sara Gerke & Sven Haller, “Artificial Intelligence Tools in Clinical Neuroradiology: Essential Medico Legal Aspects,” NEURORADIOLOGY (2023). 

Mindy N. Duffourc & Sara Gerke, “The Proposed EU Directives for AI Liability Leave Worrying Gaps Likely to Impact Medical AI,” 6 NPJ DIGITAL MEDICINE Article number: 77 (2023).

Michael Bretthauer, Sara Gerke, Cesare Hassan, Omer F. Ahmad & Yuichi Mori, “The New European Medical Device Regulation: Balancing Innovation and Patient Safety,” ANNALS OF INTERNAL MEDICINE (2023).

Sara Gerke, “‘Nutrition Facts Labels’ for Artificial Intelligence/Machine Learning-Based Medical Devices — The Urgent Need for Labeling Standards,” 91 The George Washington Law Review 79 (2023).

Carmel Shachar & Sara Gerke, “Prevention of Bias and Discrimination in Clinical Practice Algorithms,” 329 JAMA 283 (2023).

Kristin M. Kostick-Quenet & Sara Gerke, “AI in the Hands of Imperfect Users,” 5 NPJ DIGITAL MEDICINE Article number: 197 (2022).

Craig M. Klugman & Sara Gerke, “Rise of the Bioethics AI: Curse or Blessing?” 22 The American Journal of Bioethics 35 (2022).

Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen & Barbara E. Bierer, “When is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research,” 44 Ethics & Human Research 2 (2022). 

Sara Gerke, “Health AI for Good Rather than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices,” 20 YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS 433 (2021, published April 2022). 

Sara Gerke & Delaram Rezaeikhonakdar, “Privacy Aspects of Direct-to-Consumer Artificial Intelligence/Machine Learning Health Apps,” 6 Intelligence-Based Medicine 100061 (2022). 

Georgia R. Goodman, Anna Kikut, Maria J. Bustamante, Lizette Mendez, Yassir Mohamed, Carmel Shachar, I. Glenn Cohen, Sara Gerke, Edward W. Boyer, Rochelle K. Rosen, Kenneth H. Mayer, Conall O’Cleirigh & Peter R. Chai, “I’d Feel Like Someone Was Watchin’ Me… Watching for a Good Reason”: Perceptions of Data Privacy, Access, and Sharing in the Context of Real-Time PrEP Adherence Monitoring Among HIV-Negative MSM With Substance Use, AIDS and Behavior (2022).

Kristin M. Kostick-Quenet, I. Glenn Cohen, Sara Gerke, Bernard Lo, James Antaki, Faezah Movahedi, Hasna Njah, Lauren Schoen, Jerry E. Estep & J.S. Blumenthal-Barby, “Mitigating Racial Bias in Machine Learning,” 50 JOURNAL OF LAW, MEDICINE & ETHICS 92 (2022).

Julia Amann, Dennis Vetter, Stig Nikolaj Blomberg, Helle Collatz Christensen, Megan Coffee, Sara Gerke, Thomas K. Gilbert, Thilo Hagendorff, Sune Holm, Michelle Livne, Andy Spezzatti, Inga Strümke, Roberto V. Zicari & Vince Istvan Madai, “To Explain or Not to Explain? — Artificial Intelligence Explainability in Clinical Decision Support Systems,” 1 PLOS DIGIT HEALTH e0000016 (2022).

Kelly N. Michelson, Craig M. Klugman, Abel N. Kho & Sara Gerke, “Ethical Considerations Related to Using Machine Learning-Based Prediction of Mortality in the Pediatric Intensive Care Unit,” 247 THE JOURNAL OF PEDIATRICS 125 (2022).

Marc A. Rodwin & Sara Gerke, “German Pharmaceutical Pricing: Lessons for the United States,” 52 INTERNATIONAL JOURNAL OF HEALTH SERVICES 146 (2022).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, “Beware Explanations From AI in Health Care,” 373 SCIENCE 284 (2021).

George Maliha, Sara Gerke, Ravi B. Parikh & I. Glenn Cohen, “To Spur Growth in AI, We Need a New Approach to Legal Liability,” HARVARD BUSINESS REVIEW (2021).

Roberto V. Zicari, James Brusseau, Stig N. Blomberg, Helle Collatz Christensen, Megan Coffee, Marianna B Ganapini, Sara Gerke, Thomas Krendl Gilbert, Eleanore Hickman, Elisabeth Hildt, Sune Holm, Ulrich Kühne, Vince I. Madai, Walter Osika, Andy Spezzatti, Eberhard Schnebel, Jesmin J. Tithi, Dennis Vetter, Magnus Westerlund, Renee Wurth, Julia Amann, Antun Vegard, Valentina Beretta, Frédérick Bruneault, Erik Campano, Boris Düdder, Alessio Gallucci, Emmanuel Goffi, Christoffer B. Haase, Thilo Hagendorff, Pedro Kringen, Florian Möslein, Davi Ottenheimer, Matiss Ozols, Laura Palazzani, Martin Petrin, Karin Tafur, Jim Tørresen, Holger Volland & Georgios Kararigas, “On Assessing Trustworthy AI in Healthcare. Machine Learning as a Supportive Tool to Recognize Cardiac Arrest in Emergency Calls,” 3 FRONTIERS IN HUMAN DYNAMICS 673104 (2021).

Sara Gerke, Gali Katznelson, Dorit Reiss & Carmel Shachar, “COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations,” 49 THE JOURNAL OF LAW, MEDICINE & ETHICS 293 (2021).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, “Direct-to-Consumer Medical Machine Learning and Artificial Intelligence Applications,” 3 NATURE MACH. INTELL. 283 (2021).

George Maliha, Sara Gerke, I. Glenn Cohen & Ravi B. Parikh, “Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation,” 99 MILBANK Q. 629 (2021).

Gali Katznelson & Sara Gerke, “The Need for Health AI Ethics in Medical School Education,” 26 ADV. IN HEALTH SCI. EDUC. 1447 (2021).

Boris Babic, I. Glenn Cohen, Theodoros Evgeniou & Sara Gerke, “When Machine Learning Goes Off the Rails,” HARV. BUS. REV. (2021).

W. Nicholson Price II, Sara Gerke & I. Glenn Cohen, “How Much Can Potential Jurors Tell Us about Liability for Medical Artificial Intelligence?,” 62 JNM 15 (2021).

Boris Babic, I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke & Nikos Trichakis, “Can AI Fairly Decide Who Gets an Organ Transplant?,” HARVARD BUSINESS REVIEW (2020).

I. Glenn Cohen, Sara Gerke & Daniel B. Kramer, “Ethical and Legal Implications of Remote Monitoring of Medical Devices,” 98 MILBANK Q. 1257 (2020).

Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, “Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19,” 26 NATURE MED. 1176 (2020).

Hrefna D. Gunnarsdóttir, Michael S. Sinha, Sara Gerke & Timo Minssen, “Applying the Proportionality Principle to COVID-19 Antibody Testing,” J. L. BIOSCI. lsaa058 (2020).

Sara Gerke, Ariel D. Stern & Timo Minssen, “Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries,” 3 NPJ DIGIT. MED. Article number: 94 (2020).

I. Glenn Cohen, Theodoros Evgeniou, Sara Gerke & Timo Minssen, “The European Artificial Intelligence Strategy: Implications and Challenges for Digital Health,” 2 THE LANCET DIGITAL HEALTH E376 (2020).

Carmel Shachar, Sara Gerke & Eli Y. Adashi, “AI Surveillance during Pandemics: Ethical Implementation Imperatives,” 50 HASTINGS CENT. REP. 18 (2020).

Timo Minssen, Sara Gerke, Mateo Aboy, Nicholson Price & I. Glenn Cohen, “Regulatory Responses to Medical Machine Learning,” J. L. BIOSCI. lsaa002 (2020).

Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, “The Need for a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device,” 3 NPJ DIGIT. MED. Article number: 53 (2020).

Sara Gerke, Serena Yeung & I. Glenn Cohen, “Ethical and Legal Aspects of Ambient Intelligence in Hospitals,” 323 JAMA 601 (2020).

I. Glenn Cohen, Eli Y. Adashi, Sara Gerke, César Palacios-González & Vardit Ravitsky, “The Regulation of Mitochondrial Replacement Techniques Around the World,” 21 ANNU. REV. GENOM. HUM. 565 (2020).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, “Algorithms on Regulatory Lockdown in Medicine: Prioritize Risk Monitoring to Address the ‘Update Problem’,” 366 SCIENCE 1202 (2019).

W. Nicholson Price II, Sara Gerke & I. Glenn Cohen, “Potential Liability for Physicians Using Artificial Intelligence,” 322 JAMA 1765 (2019).

Mateo Aboy, Kathleen Liddell, Cristina Crespo, I. Glenn Cohen, Johnathon Liddicoat, Sara Gerke, & Timo Minssen, “How Does Emerging Patent Case Law in the US and Europe Affect Precision Medicine?,” 37 NATURE BIOTECHNOL. 1118 (2019).

Sara Gerke, Timo Minssen, Helen Yu & I. Glenn Cohen, “Ethical and Legal Issues of Ingestible Electronic Sensors,” 2 NATURE ELECTRON. 329 (2019).

Sara Gerke & Shaun Pattinson, “EU Marketing Authorisation of Orphan Medicinal Products and Its Impact on Related Research,” 24 EUR. J. HEALTH L. 541 (2017).

Jochen Taupitz, Franz Geisthövel, Dagmar Coester-Waltjen, Helmut Frister, Monika Frommel, Sara Gerke, Benjamin Hermes, Friedhelm Hufen, Alexandra Ochsner, Henning Beier & Christian Thaler, V. Mannheimer Workshop zur Fortpflanzungsmedizin: Ein juristischer Diskurs zur Präimplantationsdiagnostik und Embryonenspende auf der Basis neuerer reproduktionsbiologischer Prämissen [5th Mannheim Workshop on Reproductive Medicine: A Legal Discourse on Preimplantation Diagnosis and Embryo Donation Based on Recent Reproductive Biological Premises], 12 JOURNAL OF REPROD. MED. AND ENDOCRINOL. 42 (2015).

Book Chapters

W. Nicholson Price II, Sara Gerke & I. Glenn Cohen, Liability for Use of Artificial Intelligence in Medicine, in Research Handbook on Health, AI and the Law (Barry Solaiman & I. Glenn Cohen eds., Edward Elgar Publishing Ltd., forthcoming 2024).

Sara Gerke, Ethical and Legal Issues in Artificial Intelligence-Based Cardiology, in Intelligence-Based Cardiology and Cardiac Surgery, 415 (Anthony C. Chang and Alfonso Limon eds., Elsevier 2023).

Sara Gerke, Privacy Laws in the USA, Europe, and South Africa, in AI in Clinical Medicine: A Practical Guide for Healthcare Professionals, 395 (Michael F. Byrne et al. eds., Wiley, 2023).

Timo Minssen & Sara Gerke, Ethical and Legal Challenges of Digital Medicine in Pandemics, in Pandemics and Ethics 165 (Andreas Reis, Martina Schmidhuber & Andreas Frewer eds., Springer 2023).

Jenna Becker, Sara Gerke & I. Glenn Cohen, The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues, in Handbook of Bioethical Decisions, Volume I. Decisions at the Bench 441 (Erick Valdés & Juan Alberto Lecaros eds., Springer 2023).

Hrefna D. Gunnarsdóttir, I. Glenn Cohen, Timo Minssen & Sara Gerke, The Ethics and Laws of Medical Big Data, in The Cambridge Handbook of Information Technology, Life Sciences and Human Rights (M. Ienca, O. Pollicino, L. Liguori, E. Stefanini & R. Andorno eds., Cambridge University Press 2022).

Sara Gerke, Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward, in The Future of Medical Device Regulation: Innovation and Protection (I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson & Carmel Shachar eds., Cambridge University Press 2022).

Timo Minssen & Sara Gerke, Ethische und rechtliche Herausforderungen digitaler Medizin in Pandemien [Ethical and Legal Challenges of Digital Medicine in Pandemics], in Pandemien und Ethik [Pandemics and Ethics] 179 (Andreas Reis, Martina Schmidhuber & Andreas Frewer eds., Springer 2021).

Sara Gerke, Timo Minssen & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence-Driven Healthcare, in Artificial Intelligence in Healthcare 295 (Adam Bohr & Kaveh Memarzadeh eds., Elsevier 2020).

Sara Gerke, Die klinische Translation von hiPS-Zellen in Deutschland [The Clinical Translation of hiPSCs in Germany], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 243 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke & Solveig Lena Hansen, Die Klinische Anwendung von hiPS-Zellen: Ein Überblick [The Clinical Application of hiPSCs: An Overview], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 1 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke, Solveig Lena Hansen, Verena Christine Blum, Stephanie Bur, Clemens Heyder, Christian Kopetzki, Ina Meiser, Julia C. Neubauer, Danielle Noe, Claudia Steinböck, Claudia Wiesemann, Heiko Zimmermann & Jochen Taupitz, Naturwissenschaftliche, ethische und rechtliche Empfehlungen zur klinischen Translation der Forschung mit humanen induzierten pluripotenten Stammzellen und davon abgeleiteten Produkten [Scientific, Ethical, and Legal Recommendations for the Clinical Translation of Research Using Human Induced Pluripotent Stem Cells and Derived Products], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 459 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke, Christian Kopetzki, Verena Christine Blum, Danielle Noe & Claudia Steinböck, Eine rechtsvergleichende Analyse der klinischen Translation von hiPS-Zellen in Deutschland und Österreich [A Comparative Legal Analysis of the Clinical Translation of hiPSCs in Germany and Austria], in Die klinische Anwendung von humanen induzierten pluripotenten Stammzellen [The Clinical Application of Human Induced Pluripotent Stem Cells] 421 (Sara Gerke et al. eds., Springer 2020).

Sara Gerke & Jochen Taupitz, Rechtliche Aspekte der Stammzellforschung in Deutschland: Grenzen und Möglichkeiten der Forschung mit humanen embryonalen Stammzellen (hES Zellen) und mit humanen induzierten pluripotenten Stammzellen (hiPS Zellen) [Legal Aspects of Stem Cell Research in Germany: Limits and Possibilities of Research Using Human Embryonic Stem Cells (hESCs) and Human Induced Pluripotent Stem Cells (hiPSCs)], in Stammzellforschung: Aktuelle wissenschaftliche und gesellschaftliche Entwicklungen [Stem Cell Research: Current Scientific and Social Developments] 209 (Martin Zenke, Lilian Marx-Stölting & Hannah Schickl eds., Nomos 2018).

Blogs

Sara Gerke, Ethical and Legal Challenges Posed by the Implementation of AI Applications in the Healthcare Setting, ELSIHUB COLLECTIONS (2022).

Sara Gerke & Chloe Reichel, Should We Regulate Direct-to-Consumer Health Apps?, BILL OF HEALTH (2021).

Sara Gerke & Chloe Reichel, Mitigating Bias in Direct-to-Consumer Health Apps, BILL OF HEALTH (2021).

Sara Gerke & Chloe Reichel, Who Owns the Data Collected by Direct-to-Consumer Health Apps?, BILL OF HEALTH (2021).

Sara Gerke & Chloe Reichel, Should Users Have Access to Data Collected by Direct-to-Consumer Health Apps?, BILL OF HEALTH (2021).

Sara Gerke & Chloe Reichel, Perspectives on Data Privacy for Direct-to-Consumer Health Apps, BILL OF HEALTH (2021).

Boris Babic, Sara Gerke, Theodoros Evgeniou & I. Glenn Cohen, The Hidden Hazards of Smart Device Medical Advice, INSEAD.

Carmel Shachar, Sara Gerke & I. Glenn Cohen, Maximizing the Use of Claims Data to Address COVID-19: We Need To Revisit Gobeille v. Liberty Mutual, HEALTH AFFAIRS BLOG (2020).

Sara Gerke, Germany’s Response to the COVID-19 Pandemic, BILL OF HEALTH (2020).

Sara Gerke & I. Glenn Cohen, Ethical and Legal Issues of Ingestible Electronic Sensors: Behind the Paper, NATURE RES. DEVICE & MATER. ENG. Reposted on BILL OF HEALTH (2019).

Timo Minssen, Sara Gerke & Carmel Shachar, Is Data Sharing Caring Enough About Patient Privacy? Part II: Potential Impact on US Data Sharing Regulations, BILL OF HEALTH (2019).

Timo Minssen, Sara Gerke & Carmel Shachar, Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background, BILL OF HEALTH (2019).

Sara Gerke & Joshua Feldman, The Tricky Task of Defining AI in the Law, BILL OF HEALTH (2018).

Sara Gerke, The German Stem Cell Network Has Compiled a Sample Text for Informed Consent, BILL OF HEALTH (2018).

Sara Gerke, The EU’s GDPR in the Health Care Context, BILL OF HEALTH (2018).

Guidelines

World Health Organization (WHO), Ethics & Governance of Artificial Intelligence for Health (2021) (External Reviewer).

German Stem Cell Network (GSCN) together with the ELSA working group and the Pluripotent Stem Cell Core Network (PluriCore Network), Informed Consent Sample Text for the Donation of Somatic Cells for Human Induced Pluripotent Stem Cell (hiPSC) Research (2018).

Magazine Articles/Op-Eds

Boris Babic & Sara Gerke, Explaining Medical AI Is Easier Said Than Done, STAT (2021).

Sara Gerke, Daniel Kramer & I. Glenn Cohen, Ethical and Legal Challenges of Artificial Intelligence in Cardiology, 2 AIMED MAG. 12 (2019).

Sara Gerke & Tobias Cantz, ELSA: A New Working Group of the GSCN, FUTURE OF STEM CELL RESEARCH: ANNUAL MAGAZINE OF THE GERMAN STEM CELL NETWORK 2017/18, 47 (2018).

Working Paper and Miscellaneous

Sara Gerke, Transcript: Presentation on Data Privacy Questions in the Digital Health World, 35 J.L. & Health 449 (2022).

David Arney, Max Senges, Sara Gerke, Cansu Canca, Laura Haaber Ihle, Nathan Kaiser, Sujay Kakarmath, Annabel Kupke, Ashveena Gajeele, Stephen Lynch & Luis Melendez, A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance (2019).

Gerke’s Affiliations and Service to the Community

Member, AMERICAN BAR ASSOCIATION (ABA) (August 2023–Present)

  • Sections:
    • Health Law
    • Science & Technology Law
    • Legal Education and Admissions to the Bar

Member, FEDERATION OF STATE MEDICAL BOARDS OF THE UNITED STATES, INC. (FSMB) Ethics and Professionalism Committee, Washington, DC (June 2023–Present).

Member, AMERICAN SOCIETY FOR BIOETHICS AND HUMANITIES (ASBH), Bioethics and Artificial Intelligence Affinity Group (April 2023–Present).

Member, AMERICAN TELEMEDICINE ASSOCIATION (ATA), Data Privacy Workgroup, Arlington, VA (March 2023–Present). 

Member, Editorial Board, NPJ DIGITAL MEDICINE (November 2022–Present). 

Member, PENN STATE CANCER INSTITUTE, Milton S. Hershey Medical Center, Penn State College of Medicine, Hershey, PA (September 2022–Present). 

Member, Faculty Rights and Responsibilities Committee, PENN STATE DICKINSON LAW, Carlisle, PA (August 2022–Present).

Member, International Programs and Graduate Education Committee, PENN STATE DICKINSON LAW, Carlisle, PA (August 2022–Present).

Member, Regulation and Innovation in the Biosciences (RIBS) Steering Committee (July 2022–Present). 

Member, S.J.D. Program, Core Faculty, PENN STATE DICKINSON LAW, Carlisle, PA (April 2022–Present). 

Member, American Health Law Association (January 2022–Present). 

Member, THE ASSOCIATION OF AMERICAN LAW SCHOOLS (AALS) (November 2021–Present). 

  • Sections
    • Comparative Law (October 2023–Present)
    • European Law (October 2023–Present)
    • Internet and Computer Law (October 2023–Present)
    • Law, Medicine, and Health Care (November 2021–Present)
    • Biolaw (November 2021–Present)

Member, 1L Faculty Working Group, PENN STATE DICKINSON LAW, Carlisle, PA (August 2021–Present). 

Member, Ethical, Legal, and Social Issues (ELSI) Group, DARPA’S ADVANCED ACCLIMATION AND PROTECTION TOOL FOR ENVIRONMENTAL READINESS (ADAPTER) PROGRAM (April 2021–Present). 

Member, Stem Cell Research Oversight (SCRO) committee, SANA BIOTECHNOLOGY (February 2021–Present).

Research Member (Health Law), Z-INSPECTION® INITIATIVE (November 2020–Present).

Member, Advisory Group – Academic, AMERICAN BOARD OF AI IN MEDICINE (ABAIM) (May 2020–Present).

Initiator, ELSI Strategic Working Group, together with Tobias Cantz, GERMAN STEM CELL NETWORK (GSCN) (September 2017–Present).

Member, ASSOCIATION FOR THE PROMOTION OF GERMAN, EUROPEAN AND INTERNATIONAL MEDICAL LAW, HEALTH LAW AND BIOETHICS IN MANNHEIM AND HEIDELBERG, Germany (March 2014–Present).

Gerke’s Active Research Grants

CLASSICA (Validating AI in Classifying Cancer in Real-Time Surgery)
European Union, Horizon Europe (Grant Agreement no. 101057321)
Role: Principal Investigator (PSU); Co-Principal Investigator, WP8 (Legal, Ethical & Liability)
Dates: May 2022 – April 2026
See also https://classicaproject.eu/

OperA (Optimising Colorectal Cancer Prevention through Personalised Treatment with Artificial Intelligence)
European Union, Horizon Europe (Grant Agreement no. 101057099)
Role: Principal Investigator (PSU); Co-Principal Investigator, WP4 (Addressing Ethical/Legal Concerns)
Dates: September 2022 – August 2027
See also https://www.opera.uio.no/

PREMIERE: A PREdictive Model Index and Exchange Repository
National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institutes of Health Office of the Director (NIH OD) (Grant Agreement no. 3R01EB027650-03S1)
Role: Co-Investigator (Supplemental Project PSU)
Dates: September 2022 – May 2024

BLAST (Bioethical, Legal, and Anthropological Study of Technologies)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institutes of Health Office of the Director (NIH OD) (Grant Agreement no. 1R21EB035474-01)
Role: Multiple Principal Investigator
Dates: September 2023 – August 2025

TCORS: Tobacco Product Composition Effects on Toxicity
National Institute on Drug Abuse (NIDA)/National Institutes of Health (NIH) (Grant Agreement no. 1U54DA058271-01)
Role: Co-Investigator (September 2023 – August 2024)
Dates: September 2023 – August 2028

Gerke’s Team

Team Member (Former Postdoctoral Fellow)
Mindy Nunez Duffourc, J.D. (CLASSICA project) 

S.J.D. Scholars
Delaram Rezaeikhonakdar, LL.M., LL.M.
Lyubomir Avdzhiyski, LL.M

Current Research Assistants 
Lyubomir Avdzhiyski, LL.M (Student Fellow, CLASSICA project)
Jacob Balamut; J.D.; MPH Candidate, Penn State College of Medicine
Madeleine Kuhns-Baione; B.A.; J.D./MBA Candidate, Class of 2024, Penn State Dickinson Law
Abraham L. Lamptey; PhD; J.D. Candidate, Class of 2024, Penn State Dickinson Law 
Kaci McNeave; MSHCM; J.D. Candidate, Class of 2024, Penn State Dickinson Law (Student Fellow, CLASSICA project)
Robin Platte; B.A.; J.D. Candidate, Class of 2024, Penn State Dickinson Law (Student Fellow, CLASSICA project)

Teaching Assistants (Torts)
Camille Darius; J.D. Candidate, Class of 2025, Penn State Dickinson Law (Fall 2023)
Brandon Shepherd; B.A.; J.D. Candidate, Class of 2024, Penn State Dickinson Law (Fall 2022)
Talia N. Kowalski; B.A.; J.D. Candidate, Class of 2023, Penn State Dickinson Law (Fall 2021)